RENEWED
What it found
The main measure did not show a significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| FF-VEP Latency of the Affected Eye as Compared to the Baseline of the Fellow Eye at 2 Years (+ up to 12 Months) After the Last Study Visit Assessment (Week 32) in RENEW Study (NCT01721161) | Mean Difference (Final Values) -6 | -14.56–2.57 | =0.165 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Opicinumab
Leucine-rich repeat and immunoglobulin-like domain-containing nogo receptor-interacting protein 1 inhibitor
Placebo or sham
- Placebo
Results by group
FF-VEP Latency of the Affected Eye as Compared to the Baseline of the Fellow Eye at 2 Years (+ up to 12 Months) After the Last Study Visit Assessment (Week 32) in RENEW Study (NCT01721161)
Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Placebo | 100.68 milliseconds (msec) | 4.854 (Standard Deviation) | 23 |
| BIIB033 (Opicinumab) 100 mg/kg | 102.29 milliseconds (msec) | 5.507 (Standard Deviation) | 24 |
| Placebo | 119.52 milliseconds (msec) | 13.395 (Standard Deviation) | 23 |
| BIIB033 (Opicinumab) 100 mg/kg | 114.20 milliseconds (msec) | 14.235 (Standard Deviation) | 24 |
Placebo
BIIB033 (Opicinumab) 100 mg/kg
Placebo
BIIB033 (Opicinumab) 100 mg/kg
p = =0.165; Mean Difference (Final Values) -6 (95% CI -14.56–2.57)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Placebo | 24 | 0 (0.0%) | 0 |
| BIIB033 (Opicinumab) 100 mg/kg | 28 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
FF-VEP Latency of the Affected Eye as Compared to the Baseline of the Fellow Eye at 2 Years (+ up to 12 Months) After the Last Study Visit Assessment (Week 32) in RENEW Study (NCT01721161)
Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915)
Myelin repairNerve conduction tests
Other measures (8)
Number of Participants That Developed Clinically Definite Multiple Sclerosis (CDMS) After Enrollment in RENEW Study (NCT01721161)
RENEW Study (NCT01721161) to Day 1 (NCT02657915)
Time to Diagnosis of CDMS
RENEW Study (NCT01721161) to Day 1 (NCT02657915)
Severity of Central Nervous System (CNS) Demyelinating Disease as Assessed Using the Expanded Disability Status Scale (EDSS)
Day 1 (NCT02657915)
Disability progressionWalking and mobilityBladder, bowel and sexual functionPainSeverity of CNS Demyelinating Disease as Assessed Using the Symbol- Digit Modalities Test (SDMT)
Day 1 (NCT02657915)
Thinking and memorySeverity of CNS Demyelinating Disease as Assessed Using the Multiple Sclerosis Functional Composite (MSFC) Assessment
Day 1 (NCT02657915)
Disability progressionThinking and memoryWalking and mobilityChange in Number of Gadolinium (Gd)-Enhanced Lesions From Baseline in RENEW Study (NCT01721161) to Day 1 (NCT02657915)
Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915)
MRI lesionsChange in Volume of T2 Lesions From Baseline in RENEW Study (NCT01721161) to Day 1 (NCT02657915)
Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915)
MRI lesions- Evaluate incidence of CDMS and time to diagnosis of CDMS.
Who could take part
Optic neuritis · 18 and over
Key Inclusion Criteria: * Must have participated in Study NCT01721161 and received at least 1 dose of BIIB033 or placebo, as per protocol, within 2 years (+ 4 months) from Day 1 of this study (2 years from Week 32 or projected Week 32 visit, if the subject did not complete all visits in Study NCT01721161). Key Exclusion Criteria: * Not previously enrolled in Study NCT01721161 * Subjects with recent kidney function, such as serum creatinine above upper limit of normal range, will not be allowed to receive administration of Gd but will otherwise be allowed to participate in the study, including magnetic resonance imaging (MRI) assessments not requiring the use of Gd. * Female subjects must have had a recent pregnancy test and must not be breastfeeding prior to MRI assessments with Gd. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The primary objective of the study is to assess full-field visual evoked potential (FF-VEP) latency in subjects who were enrolled in Study NCT01721161 2 years (+ up to 12 months) after the last study visit. The secondary objective is to assess clinical progression and severity of central nervous system (CNS) demyelinating disease in subjects who were enrolled in Study NCT01721161 2 years (+ up to 12 months) after the last study visit. Intervention was administered in the previous study. The participants, investigator and outcome assessors remain blinded in this follow-up study.
Papers
Results
RENEWED: A follow-up study of the opicinumab phase 2 RENEW study in participants with acute optic neuritis.Mult Scler Relat Disord · 2025
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Linked trials
Extension of
BIIB033 In Acute Optic Neuritis (AON)Phase 2 · Completed
Links found where a registry record names another trial's registry number.
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History
Started
Mar 2016
Main results due
Jan 2017
Finished
Jan 2017
Results posted
Sept 2019
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